Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011977
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECADRON DEXAMETHASONE SODIUM PHOSPHATE EQ 0.05% PHOSPHATE OINTMENT;OPHTHALMIC Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/02/1959 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/10/1995 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1994 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1994 SUPPL-26 Labeling

Label is not available on this site.

12/28/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/25/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/26/1992 SUPPL-22 Labeling

Label is not available on this site.

12/07/1987 SUPPL-21 Labeling

Label is not available on this site.

05/30/1989 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/15/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/31/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/15/1982 SUPPL-16 Labeling

Label is not available on this site.

05/29/1986 SUPPL-15 Labeling

Label is not available on this site.

06/24/1981 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/21/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1980 SUPPL-12 Labeling

Label is not available on this site.

05/19/1976 SUPPL-11 Labeling

Label is not available on this site.

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